Latest news with #MIRA
Auto Express
6 days ago
- Automotive
- Auto Express
Euro NCAP car crash safety ratings get major four-pronged shake-up
A comprehensive overhaul of the Euro NCAP safety ratings will see current assessments replaced next year by ratings across 'four pillars of safety' – safe driving, crash avoidance, crash protection, and post-crash safety – from next year. Euro NCAP will realign many of its existing test protocols into the four new categories, but there'll be new protocols too, especially in the area of ratings for Advanced Driver Assistance Systems (ADAS). We caught up with Euro NCAP's Technical Manager ADAS/AD, Adriano Palao, during testing of the Renault 5 at MIRA, and he told us why the changes are needed. Advertisement - Article continues below 'We are very careful to only introduce scenarios in the assessment that can happen in real life,' he said, 'but there are missing pieces and we still have room for improvement. 'We started robustness activity around two and a half years ago, as we were keen to understand how sensitive our testing was to small changes. What happens when you move the car a little bit to the left or to the right? What happens in a scenario that was supposed to be completely free of objects, if you suddenly introduce a car next to the main target? These little variations actually have a tremendous effect on the performance of ADAS,' he claims. Skip advert Advertisement - Article continues below 'That led us to understand that some vehicle manufacturers were actually sub-optimising their systems to perform well in our tests, and not in real-world situations,' Palao told us, while also acknowledging others have 'a consistent and thorough approach' that optimises for the real world, and not for NCAP scenarios. 'As with every game that has a set of rules, you can find a trick to beat it,' he says. 'In our case there is a formula to get five stars and everyone knows how to do it. So from 2026, the way we are going to assess ADAS is going to change. We are going to reserve the right to inject layers of variation into test scenarios, to understand how sensitive systems are to changes. Because it is not our purpose to assess cars just for show, or just to say, 'Okay, this has five stars'. Our driving force has always been real-world safety outcomes.' Euro NCAP will be updating its car safety testing in four key areas for 2026. NCAP is strengthening its assessments of driver-monitoring systems to improve attention and driver engagement. Whereas drowsiness and distraction alerts are worth two points currently, from 2026 there'll be 25 points on offer for more advanced systems monitoring the driver's performance, with top ratings requiring real-time eye and head tracking, and not just sensors that can tell if you're gripping the steering wheel. Advertisement - Article continues below Skip advert Advertisement - Article continues below There'll also be points awarded for systems that can recognise and respond to signs of drug or alcohol impairment, and bring a vehicle to a halt if a driver is unresponsive. Euro NCAP is also introducing ratings for the human-machine interface, looking at the position, feel and accessibility of essential controls, This category will include the more intensive approach to testing collision-avoidance systems such as Steering Assist and Automatic Emergency Braking – building on the work Euro NCAP has already been performing for more than a decade, by introducing tests that better represent real-world accident conditions. Euro NCAP will build on its crash testing programme that focuses on the passive safety aspects of a car's design and specification. There'll be a wider focus on drivers of different shapes and sizes, to improve protection for older drivers and child occupants. There'll also be greater assessment of the risks in rollover situations, and closer focus on pedestrian safety, including structures around the windscreen. The range of upgrades to the test protocol here covers systems like eCall, which in future must include information on the number of occupants in a car in automated emergency messages. This requires the detection of occupants even when the seatbelts are unbuckled. Advertisement - Article continues below Skip advert Advertisement - Article continues below There are also updated ratings for occupant-extraction procedures, for example around opening doors if there has been a vehicle power failure. There will also be new ratings for an electric car's ability to detect and manage fire risk. New safety technologies aren't just a challenge that car manufacturers must get right. Euro NCAP itself must find ways of accurately rating the performance of vehicle systems designed to meet the increasingly tough criteria it sets. Which is why we find ourselves at the MIRA test track in Warwickshire on a bright spring morning in the company of the dedicated team charged with rating the performance of the all-new electric Renault 5. We're there at the invitation of Euro NCAP itself, which is keen to communicate how it goes about testing Advanced Driver Assistance Systems (ADAS) such as Steering Assist and Collision avoidance, as part of an effort to promote driver understanding of this increasingly ubiquitous tech. So we're going to witness the organisation's latest Assisted Driving test protocol being carried out for the first time in the UK. Or at least we'll be witnessing some of it. Euro NCAP's full 2024 Assisted Driving Test and Assessment protocol runs to nearly 60 pages, and awards points for the performance during live testing of speed assistance, adaptive cruise control, steering assistance and collision avoidance. Advertisement - Article continues below Skip advert Advertisement - Article continues below It doesn't end there either, because points are also awarded for how well manufacturers explain their systems to drivers through marketing and handbook content, and how drivers are able to engage with the systems in practice. Of course this is on top of the raft of passive crash and safety system tests carried out by Euro NCAP, which have all helped to make the organisation such an indisputably powerful force for change. In order to rate one car's performance against another, Euro NCAP must be able to systematically repeat tests within an exact set of parameters. That's not easy when a number of the protocols include the vehicle being tested in scenarios including other vehicles – cars, motorcycles and even bicycles – which can either be moving or stationary. We're here to see how NCAP assesses the performance of emergency brake assist when confronted by the particular challenge of a stationary or slow-moving obstruction that's revealed scant seconds before a potential accident, when when the car that you're following using active cruise control swerves sideways into the next lane to avoid its own collision. NCAP calls this a 'cut-out test' and awards points for active braking systems that will successfully prevent you from ploughing into the back of the stranded or slow-moving car, and more points if your emergency braking system can also avoid the motorcycle and bicycle – which are much more difficult for a test car's sensors to recognise and respond to. Advertisement - Article continues below Skip advert Advertisement - Article continues below James Buck, technical specialist for the ADAS team at MIRA, introduces us to some of the test kit, which includes an electric Peugeot E-308 adorned with rooftop aerials and an interior stuffed with very expensive electronics, including state-of-the-art positioning technology and robotic controls in the form of a servo-operated steering wheel and pedals. Inside the middle of the car, a solid vertical metal pillar supports an important-looking red box. 'That box needs to be rigidly attached to the vehicle so it doesn't judder around, because within it are accelerometers and gyroscopes, which work with the GPS antenna on top to give us an extremely precise location,' says James. 'Also on the roof is a WiFi antenna, so we can send our data over to a WiFi antenna on the test car, which has its own red box doing exactly the same thing, so both cars know exactly where the other is. 'The reason we've got the steering robot in is to make sure that when we do the test, it's very repeatable,' he continues. 'So we can do the test a hundred times and we can eliminate all variables in it. If I was to do the lane change myself around the bike, I'm never going to get it exactly the same every time. The steering robot is receiving information from the red boxes, so knows exactly where to go, and by having steering that is consistent and repeatable, we can isolate variables to make sure we're testing the vehicle's actual performance.' Advertisement - Article continues below Skip advert Advertisement - Article continues below The Peugeot is referred to in the protocol as the 'SOV' or 'secondary other vehicle' in the cut-out tests, but the potential 'target' vehicles that the test car must try to avoid colliding with are pretty special too. Not at first sight, it should probably be said, because the Global Vehicle Target (GVT), Euro NCAP Motorcyclist Target (EMT) and Euro NCAP Bicyclist Target (EBTa), are outwardly rather flimsy-looking foam constructions with a decidedly Heath-Robinson flavour. There's a good reason for that, of course, because if a collision-avoidance system fails to avoid a collision on test, the test car and occupants must be able to drive straight through the target, sending foam components flying, but leaving the test car undamaged. 'A lot of effort goes into making the targets visually correct, so the camera system thinks it's real, but the radar characteristics have to be right as well, because obviously they have to reflect like a real-life target to be picked up by vehicle radar and LiDAR [(Light Detection and Ranging] systems as well,' says James. 'So as well as the foam, they contain metallic plates or shavings hidden deep inside, so to a test vehicle's sensors they'll look just like the real thing.' Of course the targets also have to be moving for the Euro NCAP tests, which means they scoot around on computer-controlled trolleys which are just a few centimetres off the ground, allowing them to pass safely underneath a car's wheels if a collision takes place. 'The Global Vehicle Target is like a big flying carpet with a foam body on top,' James quips. 'But again, it's had a lot of development work to make sure it looks like a real car to the radar sensors.' Advertisement - Article continues below Skip advert Advertisement - Article continues below It's certainly reassuring to know that we're dealing with the 'soft target' motorcycle when it's our turn to jump in the Renault 5 and experience the test for ourselves. Interestingly, while the SOV is driven by robots, there's a test engineer in the driving seat of the Renault. Ameel Lalji leads the Euro NCAP ADAS programme at MIRA, and as we set up for our first collision-avoidance 'cut-out test', he explains the process. 'The car is going to pretty much do its own thing,' he tells us. 'I'm going to activate the Adaptive Cruise Control [ACC], set it to the closest gap to the vehicle ahead, and a speed of 70kmh. The SOV will be driving at 50mph, so we'll close in and let our car hold position. Then I'll let go of the wheel, as the car will be doing its own steering to stay in the lane.' It's getting quite exciting now, especially when Ameel goes on to explain what happens next: 'I should warn you the braking is going to be a bit aggressive,' he says. 'Because we're following under ACC, when the SOV ahead of us cuts out of our lane, the first thing our car will do is try to accelerate up to its set speed of 70kmh. Then, when it recognises the obstruction ahead, it should slam on emergency braking.' Advertisement - Article continues below Skip advert Advertisement - Article continues below Luckily the Renault performs exactly as hoped, and our foam motorcyclist survives the experience, braking sharply to a halt five metres short of an impact. Ameel checks his laptop and reads out the numbers: 'That was nine metres per second of deceleration, so pretty much full on at almost 1g of braking. It won't do much more than that, but it only had to do it for a second and a half,' he says. So could – or should – a real-life driver on the motorway have performed as well as the ADAS system in a real-life emergency? Well maybe, but what if they were momentarily distracted by their touchscreen or chatting to a passenger? In that case the motorcyclist might not have fared so well, and from our point of view the test was extremely affirming. As driving enthusiasts, we may not always appreciate annoying interventions from ADAS going about its business as we're going about ours, but do we really need to have to deal with the consequences of cars striking bikers or cyclists in real life to appreciate their value? We'd say no, but it's clear from our own experiences of ADAS and those related by readers, that more development is needed in some cases to ensure blemish-free operation. But intense pressure to improve standards is exactly what the Euro NCAP programme has always delivered and, unlike our Renault, it's not slowing down for the obstacles ahead. Click here for our list of the best city cars on sale ... Find a car with the experts Car Deal of the Day: Super sci-fi Kia EV6 for an exceptional £260 per month Car Deal of the Day: Super sci-fi Kia EV6 for an exceptional £260 per month Our Deal of the Day for 31 May is an extremely attractive price for this extremely capable electric family car Car Deal of the Day: new Omoda 5, with all the kit you might need, for less than £200 per month Car Deal of the Day: new Omoda 5, with all the kit you might need, for less than £200 per month The Omoda 5 is one of the newest arrivals to the family SUV market, and now it's our Deal of the Day for 1 June Audi A3 Sportback 35 TFSI long term test: premium hatch is a joy to live with Audi A3 Sportback 35 TFSI long term test: premium hatch is a joy to live with First report: premium hatch joins our fleet, and its bright metallic paint has already earned it a nickname Long-term tests 1 Jun 2025
Miami Herald
28-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical Program
The company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition. MIAMI, FL / ACCESS Newswire / May 28, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that it will participate in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has a full schedule of BIO One-on-One Partnering™ meetings planned as it explores potential licensing, strategic partnerships, and M&A opportunities. The Company's lead candidate, Ketamir-2, a next-generation oral ketamine analog, is currently undergoing a Phase 1 clinical trial. With the second dosing cohort completed, the Company is now preparing to initiate the third cohort. Building on this momentum, MIRA anticipates initiating a Phase IIa study in neuropathic pain before the end of the year, advancing the development of what the Company believes could be a safe, effective non-opioid alternative for chronic pain management. In addition, MIRA is advancing a series of preclinical studies with Ketamir-2, including models evaluating its potential in PTSD, as well as a topical formulation aimed at treating localized inflammatory pain. The Company is also finalizing regulatory filings related to its acquisition of SKNY Pharmaceuticals, Inc. ("SKNY"), with submission to the U.S. Securities and Exchange Commission (SEC) expected in the coming weeks. SKNY-1, SKNY's primary pharmaceutical candidate, is being developed as an oral therapeutic targeting smoking cessation and obesity, with activity at CB1, CB2, and MAO-B receptors. "Our pipeline is advancing on all fronts, and we are focused on turning this scientific momentum into long-term value for patients and shareholders," said Erez Aminov, Chief Executive Officer of MIRA. "As we move closer to initiating Phase IIa and completing the SKNY transaction, we're actively exploring strategic opportunities to accelerate growth, including licensing and partnerships-especially in areas like chronic pain where non-opioid alternatives like Ketamir-2 are urgently needed." Dr. Angel, Chief Scientific Advisor at MIRA, added:"We believe Ketamir-2 is paving the way for a new class of non-opioid therapies. The science is compelling, and the progress we have made is truly exciting. I look forward to sharing the depth of our work and the promising data we've generated with potential partners and investors." Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact InformationHelga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Yahoo
12-05-2025
- Business
- Yahoo
MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update
MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update Continued to make significant progress with the development of the Nanobody® sonelokimab across portfolio of indications, including Phase 3 studies in hidradenitis suppurativa (HS), psoriatic Arthritis (PsA) and adolescent HS, as well as Phase 2 studies in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA) Announced completion of enrollment of patients in the Phase 3 program in HS (the VELA program) and disclosed baseline characteristics, replicating the Phase 2 MIRA trial Presented an interim readout of the Phase 2 LEDA study in PPP, highlighting the potential of sonelokimab in an indication with currently no approved therapeutics in the US and Europe, and further derisking the overall development of sonelokimab Ended the first quarter with $480.1 million in cash, cash equivalents and short-term marketable debt securities and announced closing of a debt facility, providing up to $500 million in non-dilutive funds and extending expected cash runway into 2028 ZUG, Switzerland, May 12, 2025 – MoonLake Immunotherapeutics (NASDAQ:MLTX) ('MoonLake' or the 'Company'), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced its financial results for the first quarter of 2025. Matthias Bodenstedt, Chief Financial Officer of MoonLake Immunotherapeutics, said: 'We continue executing across our portfolio of indications with quality, speed and efficiency. Having enrolled our Phase 3 VELA program with a patient population that mirrors our Phase 2 MIRA trial further increases our confidence in the primary endpoint data which we expect to present around September 2025. The interim readout in PPP opens up another potential blockbuster indication in dermatology with a significant unmet need, and also our trials in rheumatology are progressing well. The non-dilutive facility with Hercules Capital of up to $500 million in committed capital adds to our already strong balance sheet and extends our projected cash runway into 2028, which is expected to provide us with protection from a currently volatile market and retain value for existing shareholders." Q1 highlights (including post-period end): Initiated three new trials in the beginning of 2025 with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent HS, Phase 2 LEDA trial in PPP and Phase 2 S-OLARIS trial in axSpA. Announced up to $500 million non-dilutive financing agreement with Hercules Capital Inc. (NYSE:HTGC), a leader in customized debt financing for companies in the life sciences and technology-related markets, for up to $500 million in non-dilutive capital, of which $75 million was drawn down at close and additional tranches will become available upon achievement of certain pre-specified milestones that are aligned with MoonLake's strategy and funding needs. Held an in-person and virtual Capital Markets Update in New York on Tuesday, April 29, 2025 where we: Confirmed the baseline characteristics of the VELA program with the Nanobody® sonelokimab in HS and its comparability to Phase 2 MIRA and other competitor trials following the conclusion of patient recruitment and provided narrowed guidance with respect to the timing of the primary endpoint readout Announced an earlier-than-expected interim readout of the LEDA study, highlighting the potential of sonelokimab in the evolving PPP market and further derisking the overall development of the asset First quarter 2025 financial results As of March 31, 2025, MoonLake held cash, cash equivalents and short-term marketable debt securities of $480.1 million. Research and development expenses for the quarter ended March 31, 2025, were $36.5 million, similar to the $40.4 million in the previous quarter. General and administrative expenses for the quarter ended March 31, 2025 were $11.0 million, compared to the $9.2 million incurred in the previous quarter. The increase was primarily due to personnel-related costs to support organizational growth and legal and advisory fees incurred to negotiate the non-dilutive debt facility. Important upcoming anticipated milestones for MoonLake: Initiation of Phase 2 P-OLARIS trial of Nanobody® sonelokimab in PsA and axSpA (mid 2025) Top line results for Phase 3 VELA program for the Nanobody® sonelokimab in HS (around September 2025) Primary end point readout from the Phase 2 LEDA trial, the first clinical trial in PPP for an IL-17A and IL-17F inhibitor (2H 2025) Upcoming investor and medical conferences: Jefferies Global Healthcare Conference, June 3-5, New York Goldman Sachs Annual Global Healthcare Conference, June 10-13, Miami EULAR 2025 (European Congress of Rheumatology), June 11-14, Barcelona Leerink Partners Therapeutics Forum, July 8-9, Boston GRAPPA Annual Meeting, July, 10-12, Bogotá, Colombia -Ends- About MoonLake ImmunotherapeuticsMoonLake Immunotherapeutics is a clinical-stage biopharmaceutical company unlocking the potential of sonelokimab, a novel investigational Nanobody® for the treatment of inflammatory disease, to revolutionize outcomes for patients. Sonelokimab inhibits IL-17A and IL-17F by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. The Company's focus is on inflammatory diseases with a major unmet need, including hidradenitis suppurativa and psoriatic arthritis – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake was founded in 2021 and is headquartered in Zug, Switzerland. Further information is available at About Nanobodies®Nanobodies® represent a new generation of antibody-derived targeted therapies. They consist of one or more domains based on the small antigen-binding variable regions of heavy-chain-only antibodies (VHH). Nanobodies® have a number of potential advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target terms Nanobody® and Nanobodies® are trademarks of Ablynx, a Sanofi company. About SonelokimabSonelokimab (M1095) is an investigational ~40 kDa humanized Nanobody® consisting of three VHHs covalently linked by flexible glycine-serine spacers. With two domains, sonelokimab selectively binds with high affinity to IL-17A and IL-17F, thereby inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. A third central domain binds to human albumin, facilitating further enrichment of sonelokimab at sites of inflammatory edema. Sonelokimab is being assessed in two lead indications, hidradenitis suppurative (HS) and psoriatic arthritis (PsA), and the Company is pursuing other indications in dermatology and rheumatology, including adolescent HS, palmo-plantar pustulosis (PPP) and axial spondyloarthritis (axSpA). For adults with HS, sonelokimab is being assessed in the Phase 3 trials, VELA-1 and VELA-2, following the successful outcome of MoonLake's end-of-Phase 2 interactions with the FDA and as well as positive feedback from its interactions with the EMA announced in February 2024. In June 2023, topline results of the MIRA trial (NCT05322473) at 12 weeks showed that the trial met its primary endpoint, the Hidradenitis Suppurativa Clinical Response (HiSCR) 75, which is a higher measure of clinical response versus the HiSCR50 measure used in other clinical trials, setting a landmark milestone. In October 2023, the full dataset from the MIRA trial at 24 weeks showed that maintenance treatment with sonelokimab led to further improvements in HiSCR75 response rates and other high threshold clinical and patient relevant outcomes. The safety profile of sonelokimab in the MIRA trial was consistent with previous trials with no new safety signals detected. Sonelokimab is currently undergoing evaluation in the VELA-TEEN Phase 3 trial, which is the first clinical study specifically focused on adolescent patients with moderate-to-severe HS. For PsA, sonelokimab is being assessed in the Phase 3 trials, IZAR-1 and IZAR-2, following the announcement in March 2024 of the full dataset from the global Phase 2 ARGO trial (M1095-PSA-201) evaluating the efficacy and safety of the Nanobody® sonelokimab over 24 weeks in patients with active PsA. Significant improvements were observed across all key outcomes, including approximately 60% of patients treated with sonelokimab achieving an American College of Rheumatology (ACR) 50 response and Minimal Disease Activity (MDA) at week 24. This followed the positive top-line results in November 2023, where the trial met its primary endpoint with a statistically significant greater proportion of patients treated with either sonelokimab 60mg or 120mg (with induction) achieving an ACR50 response compared to those on placebo at week 12. All key secondary endpoints in the trial were met for the 60mg and 120mg doses with induction. The safety profile of sonelokimab in the ARGO trial was consistent with previous trials with no new safety signals detected. Sonelokimab is also being assessed in the Phase 2 LEDA trial, which is ongoing for PPP, a debilitating inflammatory skin condition affecting a significant number of patients. Additionally, Sonelokimab is being assessed in the ongoing Phase 2 S-OLARIS trial for active axSpA. The trial features an innovative design complementing traditional clinical outcomes with cellular imaging techniques. Sonelokimab has also been assessed in a randomized, placebo-controlled third-party Phase 2b trial (NCT03384745) in 313 patients with moderate-to-severe plaque-type psoriasis. High threshold clinical responses (Investigator's Global Assessment Score 0 or 1, and Psoriasis Area and Severity Index 90/100) were observed in patients with moderate-to-severe plaque-type psoriasis. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab (Papp KA, et al. Lancet. 2021; 397:1564-1575). In an earlier third-party Phase 1 trial in patients with moderate-to-severe plaque-type psoriasis, sonelokimab has been shown to decrease (to normal skin levels) the cutaneous gene expression of pro-inflammatory cytokines and chemokines (Svecova D. J Am Acad Dermatol. 2019;81:196–203). About the VELA program The Phase 3 VELA program is expected to enroll 800 patients across VELA-1 and VELA-2. Both global, randomized, double-blind, and placebo-controlled trials are identical in design evaluating the efficacy and safety of the Nanobody® sonelokimab, administered subcutaneously, in adult patients with active moderate-to-severe hidradenitis suppurativa. Similar to the design of the landmark Phase 2 MIRA trial, the primary endpoint is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75, defined as a ≥75% reduction in total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline. The trials will also evaluate a number of secondary endpoints, including the proportion of patients achieving HiSCR50, the change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), the proportion of patients achieving a Dermatology Life Quality Index (DLQI) total reduction of ≥4, the proportion of patients achieving at least 50% reduction from baseline in Numerical Rating Scale (NRS50) in the Patient's Global Assessment of Skin Pain (PGA Skin Pain) and complete resolution of Draining Tunnels (DT100). Further details are available under NCT06411379 and NCT06411899 at About the VELA-TEEN trialThe Phase 3 VELA-TEEN trial is an open-label, single-arm trial designed to evaluate sonelokimab 120mg administered subcutaneously once every two weeks (Q2W) until week six and once every four weeks (Q4W) from week eight onwards. The trial aims to enroll 30-40 adolescents, aged 12-17, with moderate-to-severe hidradenitis suppurativa, from U.S. sites experienced in clinical trials and pediatric dermatology. The primary trial phase will be 24 weeks with a primary endpoint evaluating the pharmacokinetics, safety, and tolerability of sonelokimab. VELA-TEEN will also evaluate several secondary endpoints, including the proportion of patients achieving the higher clinical response measure of the Hidradenitis Suppurativa Clinical Response Score (HiSCR) 75, in addition to HiSCR50. Other outcomes are the change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4), which includes the quantitative measure of draining tunnels, and the proportion of patients achieving a meaningful reduction of the Children's Dermatology Life Quality Index (CDLQI) and the Patients Global Assessment of Skin Pain (PGA Skin Pain). Further details are available under NCT06768671 at About Hidradenitis SuppurativaHidradenitis suppurativa (HS) is a severely debilitating chronic skin condition resulting in irreversible tissue destruction. HS manifests as painful inflammatory skin lesions, typically around the armpits, groin, and buttocks. Over time, uncontrolled and inadequately treated inflammation can result in irreversible tissue destruction and scarring. The disease affects an estimated 2% of the population, with three times more females affected than males. Real-world data in the US indicates that at least 2 million unique patients have been diagnosed with and treated for HS between 2016 and 2023 alone, highlighting a significant unmet need and impact on healthcare systems, and a market opportunity projected to reach $15bn by 2035. Onset typically occurs in early adulthood and HS has a profound negative impact on quality of life, with a higher morbidity than other dermatologic conditions. There is increasing scientific evidence to support IL-17A- and IL-17F-mediated inflammation as a key driver of the pathogenesis of HS, with other identified risk factors including genetics, cigarette smoking, and obesity. About the IZAR Program IZAR-1 (NCT06641076) and IZAR-2 (NCT06641089) are global, randomized, double-blind, placebo-controlled Phase 3 trials designed to evaluate the efficacy and safety of sonelokimab compared with placebo in a total of approximately 1,500 adults with active psoriatic arthritis (PsA), with a primary endpoint of superiority to placebo in American College of Rheumatology (ACR) 50 response at Week 16. IZAR-1 is expected to enroll biologic-naïve patients and include an evaluation of radiographic progression, while IZAR-2 is expected to enroll patients with an inadequate response to tumor necrosis factor-α inhibitors (TNF-IR) — reflecting patients commonly seen in clinical practice — and is the first PsA trial to include a risankizumab active reference arm. Both trials will also assess a range of secondary endpoints reflecting the multiple disease manifestations characteristic of PsA. These include skin and nail outcomes, multidomain outcomes, and patient-reported outcome measures such as pain and quality of life assessments. Further details are available under NCT06641076 and NCT06641089 at About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, progressive and complex inflammatory disease that manifests across multiple domains, leading to substantial functional impairment and decreased quality of life. The clinical features of PsA are diverse, comprising both musculoskeletal (peripheral arthritis, spondylitis, dactylitis, and enthesitis) and non-musculoskeletal (skin and nail disease) domains. PsA occurs in up to 30% of patients with psoriasis, most commonly those aged between 30 and 60 years. Although the exact mechanism of disease is not fully understood, evidence suggests that activation of the IL-17 pathway plays an important role in the disease pathophysiology. About the S-OLARIS trialS-OLARIS is an open-label Phase 2 proof-of-concept trial aiming to investigate sonelokimab 60mg administered subcutaneously in approximately 25 patients with active axial spondylarthritis (axSpA). The primary endpoint is the change from baseline (CfB) at week 12 in the uptake of 18F-NaF in the sacroiliac joints and spine using PET in combination with MRI imaging. Throughout the trial, several other endpoints will be assessed including established clinical disease activity outcomes (e.g., ASAS), scores related to physical function, spinal mobility, and enthesitis as well as patient reported outcomes. The trial also includes an exploratory peripheral blood and tissue biomarker program. About Axial SpondyloarthritisAxial Spondyloarthritis (axSpA) typically impacts young people, with diagnosis based on chronic inflammatory back pain lasting more than three months with onset under 45 years of age. Advanced disease can lead to progressive and pathologic bone formation and joint fusion, severely limiting spinal mobility. Global reported prevalence of axSpA ranges from 0.5% to 1.5%. AxSpA can be categorized by disease progression into two subtypes: non-radiographic axSpA and ankylosing spondylitis (AS), also known as radiographic axSpA, which is diagnosed based on radiographic evidence of structural changes to the sacroiliac joints. Patients with axSpA experience fatigue, persistent morning stiffness, and pain that worsens at night and can disrupt sleep. Many patients also face the burden of comorbidities such as psoriatic arthritis and psoriasis. Studies have found elevated IL-17 levels in the blood and synovial fluid of patients with axSpA, and IL-17A and IL-17F are both thought to be key contributors to pathogenesis across the spondyloarthropathies. About the LEDA TrialThe LEDA trial is a Phase 2 trial designed to evaluate the efficacy and safety of sonelokimab 120mg administered subcutaneously in adult patients with palmoplantar pustulosis (PPP). The primary endpoint of the trial is percent change from baseline in Palmoplantar Psoriasis Area and Severity Index (ppPASI) with important secondary endpoints including ppPASI75 (at least 75% improvement in the ppPASI). The LEDA trial features an innovative translational research program using peripheral blood and tissue biomarkers as trial controls. The trial design has been informed by previous successful studies of sonelokimab, including the landmark Phase 2 MIRA trial in hidradenitis suppurativa, which identified the optimal dosing and demonstrated the potential of sonelokimab to target deep tissue inflammation effectively. About Palmoplantar PustulosisPalmoplantar Pustulosis (PPP) is characterized by the development of blister-like pustules within erythematous, scaly plaques on the palms and the soles of the feet. PPP typically develops in adulthood, more frequently impacts females. Patients frequently experience significant pain, burning, and itching sensations on the palms and soles of the feet which can be debilitating and impair their ability to work, sleep, or perform other activities of daily living. Currently, the treatment of PPP is challenging with a significant unmet need for novel therapies to reduce the symptom burden for patients. Evidence suggests that activation of the IL-17 pathway has an important role in disease pathophysiology. Cautionary Statement Regarding Forward Looking StatementsThis press release contains certain 'forward-looking statements' within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding MoonLake's expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: trial design, plans for and timing of clinical trials, including initiation of the Phase 2 P-OLARIS trial; the efficacy and safety of sonelokimab for the treatment of adult HS, adolescent HS, PPP, PsA and axSpA, including in comparison to existing standards or care or other competing therapies, clinical trials and research and development programs; the anticipated timing of the results from those studies and trials, including timing of topline results from the Phase 3 VELA program and primary endpoint readout from the Phase 2 LEDA trial; potential market opportunities for sonelokimab and MoonLake's anticipated cash position. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward looking statements. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that statement is not forward looking. Forward-looking statements are based on current expectations and assumptions that, while considered reasonable by MoonLake and its management, as the case may be, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with MoonLake's business in general and limited operating history, difficulty enrolling patients in clinical trials, state and federal healthcare reform measures that could result in reduced demand for MoonLake's product candidates, reliance on third parties to conduct and support its preclinical studies and clinical trials, the impact of general economic, health, industrial or political conditions in the United States or internationally, including recently announced tariffs and potential additional tariffs, FDA and comparable foreign regulatory authorities changes in leadership or policies or issuing additional regulations or revising existing regulations, and the other risks described in or incorporated by reference into MoonLake's Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings with the Securities and Exchange Commission, including MoonLake's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. MoonLake does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or in the events, conditions or circumstances on which any such statement is based. Contacts: MoonLake Immunotherapeutics Media & Investors Relations Carla Bretes, Director IR & External Communicationsir@ ICR Healthcare Mary-Jane Elliott, Namrata Taak, Ashley TappTel: +44 (0) 20 3709 5700MoonLake@ MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data) March 31, 2025 (Unaudited) December 31, 2024 Current assets Cash and cash equivalents $ 271,566 $ 180,426 Short-term marketable debt securities 208,564 267,601 Other receivables 2,988 2,844 Prepaid expenses 23,146 23,418 Total current assets 506,264 474,289 Non-current assets Operating lease right-of-use assets 2,589 2,922 Property and equipment, net 711 722 Other non-current assets 1,698 — Total non-current assets 4,998 3,644 Total assets $ 511,262 $ 477,933 Current liabilities Trade and other payables $ 12,006 $ 8,992 Accrued expenses and other current liabilities 10,543 12,099 Short-term portion of operating lease liabilities 1,432 1,372 Total current liabilities 23,981 22,463 Non-current liabilities Long-term debt 73,022 — Long-term portion of operating lease liabilities 1,142 1,458 Pension liability 536 621 Total non-current liabilities 74,700 2,079 Total liabilities 98,681 24,542 Commitments and contingencies (Note 16) Equity Class A Ordinary Shares: $0.0001 par value per share; 500,000,000 shares authorized; 63,474,253 shares issued and outstanding as of March 31, 2025; 63,077,431 shares issued and outstanding as of December 31, 2024 6 6 Class C Ordinary Shares: $0.0001 par value per share; 100,000,000 shares authorized; 729,320 shares issued and outstanding as of March 31, 2025; 841,269 shares issued and outstanding as of December 31, 2024 — — Additional paid-in capital 680,664 677,415 Accumulated deficit (275,537) (235,593) Accumulated other comprehensive income 2,387 4,997 Total shareholders' equity 407,520 446,825 Noncontrolling interests 5,061 6,566 Total equity 412,581 453,391 Total liabilities and equity $ 511,262 $ 477,933 MOONLAKE IMMUNOTHERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited) Three Months Ended March 31, (in thousands, except share and per share data) 2025 2024 Operating expenses Research and development $ (36,459) $ (13,014) General and administrative (11,026) (6,806) Total operating expenses (47,485) (19,820) Operating loss (47,485) (19,820) Interest expense (18) – Other income, net 7,097 5,915 Loss before income tax (40,406) (13,905) Income tax expense (153) (70) Net loss $ (40,559) $ (13,975) Of which: net loss attributable to controlling interests shareholders (39,944) (13,673) Of which: net loss attributable to noncontrolling interests shareholders (615) (302) Net unrealized gain (loss) on marketable securities and short-term investments (2,756) 182 Actuarial income on employee benefit plans 95 81 Other comprehensive income (loss) (2,661) 263 Comprehensive loss $ (43,220) $ (13,712) Comprehensive loss attributable to controlling interests shareholders (42,564) (13,416) Comprehensive loss attributable to noncontrolling interests (656) (296) Weighted-average number of Class A Ordinary Shares, basic and diluted 63,233,788 62,637,212 Basic and diluted net loss per share attributable to controlling interests shareholders $ (0.63) $ (0.22)Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Toronto Star
11-05-2025
- Entertainment
- Toronto Star
A missing novelist, an early 20th-century painter and the Brontë sisters inspire new historical fiction
'The Story She Left,' by Patti Callahan Henry, Simon & Schuster Canada, $25.99. The Story She Left Behind Patti Callahan Henry Simon & Schuster Canada, 352 pages, $25.99 Inspired by the unsolved disappearance of 25-year-old fantasy novelist Barbara Newhall Follett in 1939, Henry's fictional version concerns Bronwyn Newcastle Fordham, who walks out on her husband and child in 1927 South Carolina. In 1952, Bronwyn's daughter, Clara Harrington, an elementary school art teacher and award-winning children's book illustrator, receives a perplexing call from a London stranger, Charlie Jameson, who has a leather satchel with a manuscript; he has instructions from his recently deceased father to give it in person to Clara. She travels there with her asthmatic eight-year-old daughter Wynnie, where the Great Smog displaces them to the cleaner air of the pastoral Lake District. A Russian nesting doll of secrets is revealed — including the whereabouts of a mysterious linguistic key that will unlock the story of the second novel Bronwyn left behind when she abandoned her family — in this tender narrative about the unbreakable bond between mothers and daughters. ARTICLE CONTINUES BELOW 'The Resistance Painter,' by Kath Jonathan, Simon & Schuster Canada, $24.99. The Resistance Painter Kath Jonathan Simon & Schuster Canada, 448 pages, $24.99 In a dual timeline that artfully shifts between occupied Poland during the Second World War and Toronto in 2010, we follow the lives of two women artists, painter Irena Marianowska and her granddaughter Josephine Blum, a sculptor who specializes in graveyard monuments that reveal the life stories of the deceased. As a teenager, Irena joins the Polish resistance known as the AK, the Army Krajowa, in Warsaw, and works secretly for many years helping Jewish citizens escape through the underground network of sewers and aboveground safe houses. When a commission introduces Josephine to an ailing Polish client, Stefan, who claims to have also served in the resistance, she discovers a threatening truth about his past that leads her to the horrors of Ravensbrück and her own family history, in which her intrepid, risk-taking, beloved grandmother dared all to do what was morally right. Examining sacrifice, selflessness and resilience, Jonathan's atmospheric debut is both timely and timeless. 'Six Days in Bombay,' by Alka Joshi, MIRA, $25.99. Six Days in Bombay Alka Joshi MIRA, 352 pages, $25.99 Amrita Sher-Gil, the early 20th-century painter known as 'the Frida Kahlo of India' and the daughter of a Hungarian Jewish mother and an Indian aristocrat father, inspires the fictional biracial figurative painter Mira Novak who is at the heart of this engrossing novel that opens in 1937 Bombay. Hospitalized due to complications from a miscarriage, Mira is expected to make a full recovery. Yearning for a life larger than her own, attending nurse Sona Falstaff, only a few years younger, welcomes Mira's exotic and enchanting stories of travels and former lovers throughout Europe. ARTICLE CONTINUES BELOW ARTICLE CONTINUES BELOW When Mira dies suddenly, the hospital administration wrongly focuses on Sona, dismissing her. Even though the nurse only knew her patient for a short time, four of Mira's paintings have been left in her care to pass along to people from her past in Prague, Florence and Paris. Themes of identity and self-discovery drive this engaging portrait of young women daring to challenge societal expectations to become who they are meant to be. 'Fifteen Wild Decembers,' by Karen Powell, Europa Editions, $27. Fifteen Wild Decembers Karen Powell Europa Editions, 288 pages, $27 With its title appropriately lifted from an Emily Brontë poem, this captivating coming-of-age novel opens with six-year-old Emily joining her sisters at a girls' school in 1824, where the unsanitary conditions lead to the rampant spread of tuberculosis and the Brontës' subsequent return home to Haworth. Raised by their widowed father and his sister-in-law, and educated both at home and in boarding schools, encouraged to draw, write stories and stomp about the moors in the company of several cherished family dogs, the surviving Brontë children — Charlotte, Branwell, Emily and Anne — share lives enriched and inspired by the natural world. Powell's sumptuous, careful prose vividly recreates Victorian Yorkshire and richly conveys Emily's vibrant inner life that sets her imagination aflame as she writes 'Wuthering Heights,' its wildness in her heart. An immersive, moving, literary page-turner.
Miami Herald
08-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Announces Board Approval of SKNY Acquisition Reflecting $60+ Million in Combined Enterprise Value Based on Independent Review
With valuations confirmed by the board, MIRA advances strategic acquisition targeting obesity and nicotine dependence, which includes a $5 million contribution in cash or assets from SKNY to be transferred at closing. MIAMI, FLORIDA / ACCESS Newswire / May 8, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, Inc. (the "Merger"), following the completion of independent valuation reports on both companies. The Merger remains subject to MIRA and SKNY's shareholder approval. A third-party analysis conducted by Moore Financial Consulting ("Moore") assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5 million, based on a risk-adjusted net present value (rNPV) of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30 million, further validating the strength and synergy of the combined pipeline. As outlined in the previously announced binding letter of intent for the merger between MIRA and SKNY-1, upon the closing, SKNY must hold at least $5 million in cash or other assets, to be transferred at closing, and the Company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. As MIRA advances this merger, the combined enterprise value (based on Moore's valuations) of over $60 million represents a strong platform for expansion into high-value therapeutic markets. According to MIRA CEO Erez Aminov, the acquisition "brings together two pipelines, two market opportunities, and one unified strategy, developing targeted, first-in-class therapies for urgent public health needs." Targeting Major Markets with a Differentiated Mechanism SKNY-1 is being developed as a next-generation oral therapeutic designed to modulate CB1 and CB2 cannabinoid receptors, as well as monoamine oxidase B (MAO-B)-an enzyme involved in dopamine metabolism and addiction regulation. This multi-target mechanism is being evaluated for its potential to address both metabolic dysfunction and nicotine dependence, providing a differentiated therapeutic alternative in two of the most urgent health markets globally. The global weight loss drug market is projected to surpass $150 billion by 2030, driven by growing demand for safer and more tolerable alternatives to GLP-1-based injectables (Source: Reuters).The U.S. smoking cessation market is projected to grow from $28.11 billion in 2024 to $50.90 billion by 2030, at a CAGR of 10.4% (Source: Grand View Research). These are large, underserved markets with limited innovation, and MIRA's leadership believes the addition of SKNY-1 to the Company's pipeline enhances its ability to compete in both. Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, noted that SKNY-1's pharmacological profile, particularly its combined activity on both MAO-B and cannabinoid receptors, makes it a unique and promising candidate for craving, addiction and metabolic conditions with a sound neurochemical basis. "From a scientific perspective, this is a rationally designed molecule that addresses the biological complexity of both obesity and addiction," said Dr. Angel. "The early data are promising, and I'm looking forward to advancing its development." Strategic Value for the Future With both companies independently valued by Moore at approximately $30 million, MIRA believes this transaction creates a platform with scale, differentiated science, and a pipeline built to target urgent unmet needs. The Company views this merger as a foundation for long-term growth and innovation. Additional information about MIRA Pharmaceuticals is available at Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
